Esomeprazole Magnesium
- Product NDC
- 0363-0772
- 11-digit product format
- 003630772
- Labeler code
- 0363
- Product ID
- 0363-0772_8324c1f7-6942-be7b-e4c4-948bbaa97ed9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- WALGREENS COMPANY
- Application
- ANDA207198
- Marketing category
- ANDA
- Marketing start
- 2025-03-01
- Substance
- ESOMEPRAZOLE MAGNESIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 0363-0772_8324c1f7-6942-be7b-e4c4-948bbaa97ed9
- SPL ID
- 8324c1f7-6942-be7b-e4c4-948bbaa97ed9
- Product type
- HUMAN OTC DRUG
- Finished product
- Yes
- Brand name base
- Esomeprazole Magnesium
- Generic name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing start
- 2025-03-01
- Marketing category
- ANDA
- Application number
- ANDA207198
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA]; Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ESOMEPRAZOLE MAGNESIUM | 20 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | R6DXU4WAY9 |
| Rxcui | 606726 |
| Spl Set Id | 993f86d0-c18b-a843-6adf-e8a967da3745 |
| Manufacturer Name | WALGREENS COMPANY |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 0363-0772-14 | 1 BOTTLE in 1 CARTON (0363-0772-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2025-03-01 | No |
| 0363-0772-28 | 2 BOTTLE in 1 CARTON (0363-0772-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2025-03-01 | No |
| 0363-0772-42 | 3 BOTTLE in 1 CARTON (0363-0772-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2025-03-01 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| R6DXU4WAY9 | ESOMEPRAZOLE MAGNESIUM | 217087-09-7 | ESOMEPRAZOLE MAGNESIUM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0363-0772-14 | 00363077214 | 1 BOTTLE in 1 CARTON (0363-0772-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2025-03-01 | No | No | Historical |
| 0363-0772-28 | 00363077228 | 2 BOTTLE in 1 CARTON (0363-0772-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2 bottle | 2025-03-01 | No | No | Historical |
| 0363-0772-42 | 00363077242 | 3 BOTTLE in 1 CARTON (0363-0772-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2025-03-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Drug Facts | WALGREENS COMPANY | 2025-10-28 | HUMAN OTC DRUG LABEL | 2 |
| Drug Facts | WALGREENS COMPANY | 2024-07-29 | HUMAN OTC DRUG LABEL | 1 |